MAUDE Adverse Event Report: STRYKER SPINE-US TRITANIUM PL 7MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48955076
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; 3 minute surgical delay to get & load another implant after cage broke while being lightly impacted.
Additional Manufacturer Narrative
Method: visual analysis; material analysis; device history review; complaint history review; risk assesment; result: the customer reported event of a posterior lumbar cage main body fracture intra-op was confirmed via visual insp and correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The submitted cage was found to have fractured in ductile overload during implantation.The observed elements were found to be consistent with what was listed on the drawing.No material or manufacturing defects were found.Conclusion: the plausible root cause of the reported event is likely due to the misaligned insertion force during cage insertion impaction.The patient's very small and collapsed disc space and hard-osteophytes bone quality are the possible contributing factors for the cage fracture during the application of cantilever force.
Event or Problem Description
It was reported that; 3 minute surgical delay to get & load another implant after cage broke while being lightly impacted.

• Brand Name: TRITANIUM PL 7MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5780203
• Report Number: 3004024955-2016-00072
• Device Sequence Number: 1076575
• Product Code: MAX
• UDI-Device Identifier: 07613327118056
• UDI-Public: (01)07613327118056
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48955076
• Device Lot Number: AA10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1